Efficacy and safety of fruquintinib plus sintilimab in third-line treatment of metastatic colorectal cancer: A single-center experience

Table 1 Patient demographic and clinical characteristics

	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5	Patient 6
Sex	Female	Male	Male	Male	Female	Female
Age (years)	47	63	39	66	57	51
ECOG	0	0	0	1	0	1
Primary location	Descending colon	Rectum	Descending colon	Sigmoid colon	Ascending colon	Rectum
Primary resection	No	Yes	Yes	Yes	Yes	No
Metastatic lesion	Liver, lung, peritoneum, bone	Liver	Liver, peritoneum	Liver, bone	Liver	Liver, bone
RAS/BRAF status	BRAF mutant	NRAS mutant	Wild	KRAS mutant	KRAS mutant	KRAS mutant
MSS status	MSS	MSS	MSS	MSS	MSS	MSS
CPS	1	5	5	0	0	6
First-line	mFOLFOX6 + Bev	OXA + RTX	mFOLFOX6 + Cet	XELOX + Bev	XELOX	XELOX + Bev
PFS1 (months)	7.8	17	13.2	3.5	4.2	2.2
Second-line	CPT-11 + RTX + Bev	CPT-11 + RTX + Bev	CPT-11 + RTX + Bev	CPT-11 + RTX + Bev	CPT-11 + RTX	CPT-11 + RTX + Bev
PFS2 (months)	6.1	12.5	3.3	1.8	1.9	1.9
Third-line	Fruquintinib + sintilimab	Fruquintinib + sintilimab	Fruquintinib + sintilimab	Fruquintinib + sintilimab	Fruquintinib + sintilimab	Fruquintinib + sintilimab
PFS3 (months)	3.8	11	2.8	5.1	10	1.7
Third-line cycles	3	12	3	6	12	2
Efficacy	PD	SD	PD	PD	CR	PD
OS	5.1	17.1	5.7	6.9	10	5

ECOG: Eastern Cooperative Oncology Group; MSS: Microsatellite stability; CPS: Combined Positive Score; PFS: Progression-free survival; OS: Overall survival; mFOLFOX6: Oxaliplatin + leucovorin + fluorouracil; Bev: Bevacizumab; OXA: Oxaliplatin; RTX: Raltitrexed; Cet: Cetuximab; XELOX: Oxaliplatin + capecitabine; CPT-11: Irinotecan; CR: Complete response; SD: Stable disease; PD: Progression disease.

Table 2 Treatment regimens

Treatment regimens
mFOLFOX6 + Bev	Oxaliplatin 100 mg/m2 on day 1, leucovorin 400 mg/m2 on days 1-2, and fluorouracil 2400 mg/m2 once over 46 hours on days 1-3, bevacizumab 5 mg/kg on day 1
OXA + RTX	Oxaliplatin 130 mg/m2 on day 1, raltitrexed 3 mg/m2 on day 1
mFOLFOX6 + Cet	Oxaliplatin 100 mg/m2 on day 1, leucovorin 400 mg/m2 on days 1-2, and fluorouracil 2400 mg/m2 once over 46 hours on days 1-3, cetuximab 500 mg/m2 on day 1
XELOX	Oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1-14
XELOX + Bev	Oxaliplatin 130 mg/m2 on day 1, capecitabine 1000 mg/m2 twice daily on days 1-14, bevacizumab 7.5 mg/kg on day 1
CPT-11 + RTX	Irinotecan 200 mg/m2 on day 1, raltitrexed 3 mg/m2 on day 1
CPT-11 + RTX + Bev	Irinotecan 200 mg/m2 on day 1, raltitrexed 3 mg/m2 on day 1, bevacizumab 7.5 mg/kg on day 1
Fruquintinib + sintilimab	Fruquintinib 3 mg once daily on days 1-21, sintilimab 200 mg on day 1

mFOLFOX6: Oxaliplatin + leucovorin + fluorouracil; Bev: Bevacizumab; OXA: Oxaliplatin; RTX: Raltitrexed; Cet: Cetuximab; XELOX: Oxaliplatin + capecitabine; CPT-11: Irinotecan.

Table 3 Adverse reactions, n (%)

AEs	Grade 1	Grade 2	Grade 3
White blood cell decreased	0 (0)	1 (16.7)	0 (0)
Neutropenia	1 (16.7)	1 (16.7)	0 (0)
Anemia	4 (66.7)	0 (0)	0 (0)
Thrombocytopenia	2 (33.3)	0 (0)	0 (0)
Alanine aminotransferase increased	5 (83.3)	0 (0)	0 (0)
Aspartate aminotransferase increased	5 (83.3)	0 (0)	0 (0)
Urinary protein increased	0 (0)	1 (16.7)	0 (0)
Fatigue	0 (0)	0 (0)	0 (0)
Anorexia	0 (0)	0 (0)	0 (0)
Hypertension	0 (0)	1 (16.7)	0 (0)
Hemorrhage	0 (0)	0 (0)	0 (0)
Palmar-plantar erythrodysesthesia syndrome	0 (0)	0 (0)	1 (16.7)
Hypothyroidism	2 (33.3)	1 (16.7)	0 (0)
Myocarditis	1 (16.7)	0 (0)	0 (0)

AEs: Adverse events.